This is a prospective, double-blind placebo-controlled randomized controlled trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

The MNWS will be used to assess for change in withdrawal symptoms from the quit date (onset of smoking cessation + after 1 wk of treatment) to that at the completion of study therapy (status post 12 wks of study treatment, 11 wks post quit date).

Abstinence, that is quit rate, measured via 7-day point prevalence abstinence will be assessed at the end of study medication treatment, that is post 12 weeks of study drug treatment and again at end of pregnancy (36.0-38.6 weeks of gestation). This outcome will be assessed twice to determine a change in the quit rate from immediately status post treatment to that which occurs immediately before delivery.

Bupropion SR 150 mg po BID. We will administer a 12-week course of therapy, 150 mg bid x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.

Drug: bupropion SR 150 mg tablets or matched placebo

Bupropion SR tablets or matched placebo. We will administer a 12-week course of therapy, 150 mg bid/placebo x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg/matched placebo orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.

Other Names:

Zyban

buproban

Behavioral: Smoking Cessation Counseling

The behavioral counseling will include 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the study nurse.

Other Name: behavioral counseling

Placebo Comparator: Placebo

We will administer a 12-week course of therapy, placebo bid x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.

Drug: bupropion SR 150 mg tablets or matched placebo

Bupropion SR tablets or matched placebo. We will administer a 12-week course of therapy, 150 mg bid/placebo x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg/matched placebo orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.

Other Names:

Zyban

buproban

Behavioral: Smoking Cessation Counseling

The behavioral counseling will include 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the study nurse.

Other Name: behavioral counseling

Detailed Description:

This is a prospective, double-blind placebo-controlled randomized controlled trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy. A total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. Compassionate care/continuance of therapy will be available to pregnant subjects. Women who relapse to smoking postpartum will be offered an additional course of medication treatment. All subjects irregardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month post partum period. Subject participation will begin between 13-26 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13)months in length.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days

a personal history of closed head trauma with > 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion

use of any other smoking cessation treatment in the past 30 days

current enrollment in methadone treatment program

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390246